The FDA issued a warning letter to Ami Cosmetics in Soeul, South Korea, saying the over-the-counter drugmaker had contradictory information in its labeling and its electronic listing in the FDA’s…
Indivior won a temporary restraining order against Dr. Reddy’s to prevent the company from rolling out its generic version of the opioid addiction treatment Suboxone (buprenorphine and naloxone) following the…
The FDA cited Reliance Life Sciences for a long list of deficiencies observed during an inspection of the API manufacturer’s facility in Navi Mumbai in December. Source: Drug Industry Daily
The FDA updated its manual on handling inter-center consultation requests between CDER, CBER and CDRH for combination product reviews. Source: Drug Industry Daily
Two new FDA initiatives would promote generic competition through updated labeling and more efficient reviews, according to Commissioner Scott Gottlieb. Source: Drug Industry Daily
HHS issued a final rule to once again delay implementation of the revised Common Rule on the protection of human subjects in clinical trials for six months until Jan. 21,…
The FDA hit Eau Zone Huiles Et Fragrances with a Form 483 after an inspection determined the OTC manufacturer had numerous deficiencies at its Montreal, Quebec facility, including cleaning, testing…
Americans’ trust in drugmakers plunged in the past year to the lowest level since Edelman launched its annual Trust Barometer survey five years ago. Source: Drug Industry Daily
After a flurry of opioid- related bills passed the House earlier last week, the chamber on Friday passed legislation that will limit the availability of synthetic drugs. Source: Drug Industry…
Sen. Orrin Hatch (R-Utah) proposes to amend the landmark Hatch-Waxman Act to require generic drugmakers challenging brand patents to choose between inter partes reviews or Hatch-Waxman litigation. Source: Drug Industry…